Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries

NCT05843344 | Unknown

• 1 other identifier: 492/15-03-2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study will be to compare the effects of morphine versus dexmedetomidine when used as adjuvants to local anesthetic (Ropivacaine) in Erector Spinae Plane Block under ultrasound guidance. A group without an adjuvant will also be compared to the groups.

Conditions

Pain, Postoperative; Pain, Acute; Pain, Chronic; Morphine; Dexmedetomidine; Analgesia

Outcome Measures

Primary Outcomes (1)

• Intravenous morphine consumption in the first 48 hours post-operatively

  Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 48 hours.

  48 hours post-operatively

Secondary Outcomes (23)

• IV morphine consumption in the first 6 hours

  6 hours post-operatively

• IV morphine consumption in the first 12 hours

  12 hours post-operatively

• IV morphine consumption in the first 24 hours

  24 hours post-operatively

• Intraoperative remifentanil consumption

  Duration of operation

• Intraoperative morphine consumption

  Duration of operation

Study Arms (3)

ropivacaine and morphine group

ACTIVE COMPARATOR

erector spinae plane block with a combination of ropivacaine and morphine

Drug: erector spinae plane block with a combination of ropivacaine and morphine

ropivacaine and dexmedetomidine group

ACTIVE COMPARATOR

erector spinae plane block with a combination of ropivacaine and dexmedetomidine

Drug: erector spinae plane block with a combination of ropivacaine and dexmedetomidine

ropivacaine group

ACTIVE COMPARATOR

erector spinae plane block with ropivacaine only

Drug: erector spinae plane block with ropivacaine only

Interventions

erector spinae plane block with a combination of ropivacaine and morphine DRUG

Before surgery, a US guided ESPB will be performed, and a catheter will be placed. Serratus Anterior Plane Block (SAPB) will be also performed without catheter placement. 20 mL of Ropivacaine 0.375% will be injected in the SAPB. In this group, 19 mL of 0.375% Ropivacaine + 2 mg (1mL) of morphine will be injected in the ESPB. Continuous peripheral nerve catheters will be placed for postoperative analgesia under the Erector Spinae muscle. A pump of 497 ml of 0.2 % ropivacaine + 6 mg of morphine (contained in 3 mL) will be connected to the catheter after the end of the surgery, and the continuous dose will be 10 mL/hr

Also known as: ropivacaine plus morphine

ropivacaine and morphine group

erector spinae plane block with a combination of ropivacaine and dexmedetomidine DRUG

Before surgery, a US guided ESPB will be performed, and a catheter will be placed. SAPB will be also performed without catheter placement. 20 mL of Ropivacaine 0.375% will be injected in the SAPB. In this group, 19 mL of 0.375% Ropivacaine +0.5 mcg/kg (1mL) of dexmedetomidine will be injected in the ESPB. Continuous peripheral nerve catheters will be placed for postoperative analgesia under the Erector Spinae muscle. A pump of 497 ml of 0.2 % ropivacaine + 200 mcg of dexmedetomidine (contained in 3 mL) will be connected to the catheter after the end of the surgery, and the continuous dose will be 10 mL/hr

Also known as: ropivacaine plus dexmedetomidine

ropivacaine and dexmedetomidine group

erector spinae plane block with ropivacaine only DRUG

Before surgery, a US guided ESPB will be performed, and a catheter will be placed. SAPB will be also performed without catheter placement. 20 mL of Ropivacaine 0.375% will be injected in the SAPB. In this group, 19 mL of 0.375% Ropivacaine +1 mL of normal saline will be injected in the ESPB. Continuous peripheral nerve catheters will be placed for postoperative analgesia under the Erector Spinae muscle. A pump of 497 ml of 0.2 % ropivacaine + 3 mL of normal saline will be connected to the catheter after the end of the surgery, and the continuous dose will be 10 mL/hr

Also known as: ropivacaine only

ropivacaine group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective thoracotomy for any cause (ASA I-III)

You may not qualify if:

• known allergy to local anesthetic
• local inflammation
• severe respiratory distress ( breathing dependence on accessory muscles)
• severe spinal deformities
• severe ipsilateral diaphragmatic paresis
• morbid obesity (BMI\>35 kg/m2)
• blood coagulation disorder
• known contraindication for administration of dexmedetomidine or morphine
• severe cardiovascular disease
• systematic use of opioids due to chronic pain
• renal or hepatic failure
• patients who refuse to participate.

Sponsors & Collaborators

• Dr Kassiani Theodoraki: lead
• Sotiria General Hospital: collaborator

Study Sites (2)

Sotiria Thoracic Diseases Hospital

Athens, 11527, Greece

Location

Aretaieion University Hospital

Athens, 11528, Greece

Location

Related Publications (11)

• Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.

  PMID: 18456219 BACKGROUND

• A Mesbah, MB BCh FCAI FRCA, J Yeung, MB ChB FRCA PhD FFICM, F Gao, MB BS PhD MPhil FRCA MD FFICM, Pain after thoracotomy, BJA Education, Volume 16, Issue 1, January 2016, Pages 1-7, https://doi.org/10.1093/bjaceaccp/mkv005

  BACKGROUND

• Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.

  PMID: 24901240 BACKGROUND

• Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.

  PMID: 26897642 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.

  PMID: 30886130 BACKGROUND

• Hassan ME, Wadod MAA. Serratus anterior plane block and erector spinae plane block in postoperative analgesia in thoracotomy: A randomised controlled study. Indian J Anaesth. 2022 Feb;66(2):119-125. doi: 10.4103/ija.ija_257_21. Epub 2022 Feb 24.

  PMID: 35359482 BACKGROUND

• Hamed MA, Fargaly OS, Abdelghaffar RA, Moussa MA, Algyar MF. The role of dexmedetomidine as an adjuvant for high-thoracic erector spinae plane block for analgesia in shoulder arthroscopy; a randomized controlled study. BMC Anesthesiol. 2023 Feb 15;23(1):53. doi: 10.1186/s12871-023-02014-2.

  PMID: 36793000 BACKGROUND

• Gao Z, Xiao Y, Wang Q, Li Y. Comparison of dexmedetomidine and dexamethasone as adjuvant for ropivacaine in ultrasound-guided erector spinae plane block for video-assisted thoracoscopic lobectomy surgery: a randomized, double-blind, placebo-controlled trial. Ann Transl Med. 2019 Nov;7(22):668. doi: 10.21037/atm.2019.10.74.

  PMID: 31930069 BACKGROUND

• Ling L, Yang TX, Lee SWK. Effect of Anaesthesia Depth on Postoperative Delirium and Postoperative Cognitive Dysfunction in High-Risk Patients: A Systematic Review and Meta-Analysis. Cureus. 2022 Oct 10;14(10):e30120. doi: 10.7759/cureus.30120. eCollection 2022 Oct.

  PMID: 36381936 BACKGROUND

• Suraarunsumrit P, Pathonsmith C, Srinonprasert V, Sangarunakul N, Jiraphorncharas C, Siriussawakul A. Postoperative cognitive dysfunction in older surgical patients associated with increased healthcare utilization: a prospective study from an upper-middle-income country. BMC Geriatr. 2022 Mar 16;22(1):213. doi: 10.1186/s12877-022-02873-3.

  PMID: 35296258 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chronic Pain; Agnosia

Interventions

Morphine; Ropivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Kassiani Theodoraki, PhD, DESA

  Aretaieion UNiversity Hospital, National and Kapodistrin University of Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassiani Theodoraki, PhD DESA

CONTACT

+306974634162; ktheodoraki@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 6, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)